# K002998: Biomet BI-Polar Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Oct 6, 2000 after 10 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K800494 (1980). 3 ancestors in all.
265 later devices descend from it; 4 cite it directly.
1 of 269 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991585: Bipolar Shoulder Prosthesis, Biomet, Inc. (1999) Summary page 2.

## Most influential descendants
- K030710: Bio-Modular Shoulder System (2003), 253 descendants of its own
- K043100: Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components (2005), 176 descendants of its own
- K072804: Comprehensive RS Shoulder System (2007), 175 descendants of its own
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K010827: Copeland MB/HA Resurfacing Humeral Heads (2001), 142 descendants of its own

## Recalls of this device
- Feb 23, 2004 · Not classified · Z-0777-04: The locking ring was not included and the shoulder implanted without the locking ring.

## Indications for use
The Biomet® Bi-Polar Shoulder System is indicated for use in: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Revision where other devices or treatments have failed 4) Correction of functional deformity 5) Treatment of acute fracture of the humeral head unmanageable using other treatment methods 6) Cuff tear arthroplasty This is a single use implant for use with cemented or uncemented humeral components. It is intended for use with Biomet’s humeral components previously cleared by the FDA.

Source page: https://510kreport.com/device/K002998
Methodology: https://510kreport.com/methodology